N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-11.5

Current through Register Vol. 46, No. 45, November 2, 2024

Section 52-11.5 - Use of nontransplant anatomic parts

(a) Whenever a whole body is donated for educational purposes, unless another lawful donee is specified in the donor consent, the whole body user shall be an entity authorized to receive the bodies of deceased persons pursuant to Public Health Law, section 4211 in accordance with the priorities established therein.

(b) A whole body user shall not transfer the whole body or body segment to any other entity, except as authorized in writing by the whole body acquisition service from which the whole body or body segment was obtained.

(c) A whole body user shall have at least one staff member with a graduate degree in the health sciences, and training specific to human dissection or to the activity to be performed.

(d) In addition to the records required in section 52-2.9(i) of this Part, a whole body user shall maintain complete and accurate records of receipt, use and disposition of whole bodies, body segments, organs and tissues. These records shall include, but not be limited to:

(1) identification of the whole body, or, in the case of a body segment, a description and source of the body segment;

(2) a copy of any contract or letter of agreement between the whole body acquisition service and whole body user, and documentation of the method of final disposition of whole bodies or body segments; and

(3) in the case of whole body transfers, a copy of a properly executed burial transit permit.

(e) The dissection and/or other authorized use of whole bodies and body segments shall occur only in dedicated rooms on the premises of the facility identified on the license or at an off-site location approved by the director of the whole body acquisition service from which whole bodies and/or body segments were obtained. Such rooms shall feature:

(1) lockable doors with access restricted to individuals directly associated with the dissection and/or other authorized use;

(2) isolation from public view;

(3) sufficient size, and construction and equipment suitable to ensure safe and respectful handling of whole bodies and body segments;

(4) tables designed for dissection of whole bodies or other work spaces appropriate for the specific authorized activity to be performed;

(5) a working sink and adequate counter space to ensure the safety of individuals involved in using whole bodies and body segments in dissection or other authorized use;

(6) surfaces constructed of nonporous materials;

(7) OSHA-approved eye wash stations; and

(8) facilities for storage of chemicals, if any, in accordance with OSHA guidelines.

(f) Other nontransplant anatomic banks.

(1) All other nontransplant anatomic banks shall conduct authorized activities in spaces that feature:

(i) lockable doors with access restricted to individuals directly associated with the education and/or research activities conducted;

(ii) isolation from public view;

(iii) sufficient size, and construction and equipment suitable to ensure safe and respectful handling of the organs and/or tissues;

(iv) a working sink and adequate work space to ensure the safety of individuals involved in using organs and/or tissues in education and/or research; and

(v) surfaces constructed of nonporous materials.

(2) Nontransplant anatomic banks using nontransplant anatomic parts that are not whole bodies or segments shall maintain complete and accurate records of receipt, use and disposition of organs and tissues. These records shall include the source and a full description of each organ or tissue.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-11.5